Validation Study With a Non-CE Marked Medical Device (MD)

NCT ID: NCT05689307

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2024-11-22

Brief Summary

This interventional study aims to validate the cough detection device by automatically and continuously measuring the cough frequency with SIVA-MVP among chronic cough patients and in a real-world environment.

Detailed Description

After chronic cough diagnosis, the Principal Investigator (or his designee) will identify potentially eligible patients to participate in this study based on the predefined inclusion criteria.

The study will recruit patients with a cough that has lasted for at least 12 months and persistent for the previous 8 weeks with a diagnosis or suspicion of refractory chronic cough, or patients with a diagnosed asthma. A total of 50 patients will be enrolled in the study.

Patients who decide to participate will be entered into the study after obtaining their informed consent. They will receive the SIVA-MVP wearable and the associated accessories. They will be asked to rate their current cough severity on a visual analog scale (Cough Severity VAS) and fill in a Leicester Cough Questionnaire (LCQ) to assess the impact of cough on their quality of life. Participants will receive a second Cough Severity VAS and LCQ to fill at the end of the study and a return envelope.

Participants will receive standard care and be asked to wear SIVA-MVP on their chest during the day and charge it on the bedside during sleep for 14 days. Every evening, they will be prompted by the SIVA-MVP smartphone application to indicate the timing of their main meals.

On day 15, the study nurse will conduct a pre-scheduled phone interview with each participant. The phone interview will include instructing the patient to fill in the final Cough Severity VAS and LCQ, asking the questions of the Participant User Feedback Questionnaire, and instructing the patient to send the questionnaire forms and the SIVA-MVP wearable and the accessories back to the trial site using the return envelope. The Participant User Feedback Questionnaire will include ratings of wearing comfort, usability, and likeliness to wear for an extended period of time.

Conditions

Chronic Cough

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SIVA-MVP

Wearable cough detection device with a corresponding smartphone application and charging device.

Group Type: EXPERIMENTAL

SIVA-MVP

Intervention Type: DEVICE

Participants receive a small, wearable data recorder, wear it during the day and charge it on the nightstand during sleep for 14x24 hours. The encrypted, recorded segments are uploaded to a server. The server provides a secure environment where the segments are decrypted after receiving the required keys from the patient's SIVA smartphone application. The decrypted segments are then classified as cough by a machine learning algorithm. Participants respond to questions on a smartphone once a day for additional context data. The audio data from the first 24 hours after the patient started wearing the device are used for the validation of the performance of the cough detection algorithm.

Interventions

SIVA-MVP

Participants receive a small, wearable data recorder, wear it during the day and charge it on the nightstand during sleep for 14x24 hours. The encrypted, recorded segments are uploaded to a server. The server provides a secure environment where the segments are decrypted after receiving the required keys from the patient's SIVA smartphone application. The decrypted segments are then classified as cough by a machine learning algorithm. Participants respond to questions on a smartphone once a day for additional context data. The audio data from the first 24 hours after the patient started wearing the device are used for the validation of the performance of the cough detection algorithm.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Informed Consent as documented by signature
• Adult men and women at the date of signing the Informed Consent Form
• Patients with a diagnosis or suspicion of refractory chronic cough or patients with a diagnosed asthma
• Attending the treatment procedure as an outpatient
• Comfortable with using a smartphone and willing to use an external iPhone daily for the duration of the study.
• Adequate communication in US English (all study documentation and SIVA-MVP will be set to English language only).

Exclusion Criteria

• Unable to make the decision to participate in a clinical study (e.g., seriously ill or unconscious subject, or subject with a mental or intellectual disability)
• Inability to follow the procedures of the study, e.g., due to physical or intellectual impairment precluding informed consent or protocol adherence, psychological disorders (excluding depression) or dementia
• Use of any other medical device equipment (e.g., portable oxygen concentrator, artificial cardiac pacemaker, implantable cardioverter-defibrillator)
• Pregnancy: Female participants in child-bearing age without a negative pregnancy test (urine test). Female participants who are neither surgically sterilized / hysterectomized nor post-menopausal for longer than 2 years are considered to be of childbearing potential.
• Known or suspected non-compliance, drug or alcohol abuse
• Participation in another clinical study

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siva Health AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bellingham Asthma, Allergy & Immunology Clinic

Bellingham, Washington, United States

Countries

United States

Other Identifiers

SIVA-VS2

Identifier Type: -

Identifier Source: org_study_id